Electroacupuncture versus Sham Acupuncture for Perimenopausal Insomnia: A Randomized Controlled Clinical Trial

Figures & data

Figure 1 Study flow diagram.

Table 1 Baseline Characteristics of Participants, by Group

Characteristics	Acupuncture Group (n=42)	Sham Acupuncture Group (n=42)	P
Mean age (SD), y	52.12(4.19)	53.07(3.81)	0.279
Occupational status, n (%)			0.609
Mental activity	7 (16.67)	4 (9.52)
Physical activities	23 (54.76)	24 (57.14)
Housewife	12 (28.57)	14 (33.33)
Educational qualification, n (%)			0.866
Master degree	2 (4.76)	3 (7.14)
University degree	21 (50.00)	18 (42.86)
Secondary school	18 (42.86)	20 (47.62)
Primary school	1 (2.38)	1 (2.38)
Duration of insomnia (IQR), m	39.19 (15.0, 57.0)	40.21 (16.0, 60.0)	0.616
Alcohol use, n (%)			0.494
Yes	2 (4.76)	0 (0.00)
No	40 (95.24)	42 (100.0)
Tea use, n (%)			0.533
Yes	5(11.90)	7(16.67)
No	37(88.10)	35(83.33)
Coffee use, n (%)			0.558
Yes	6(14.29)	8(19.05)
No	36(85.71)	34(80.95)
Estazolam use, n (%)			1.000
Yes	9(21.43)	10(23.81)
No	33(78.57)	32(76.19)
PSQI score (SD)	10.88(3.23)	10.64(3.53)	0.748
Men-QoL score (SD)
Vasomotor	4.15(1.66)	3.58(1.88)	0.164
Psychosocial	2.93(1.41)	3.41(1.39)	0.057
Physical	3.27(1.07)	3.41(1.36)	0.996
Sexual	4.46(1.62)	4.83(1.89)	0.335
ISI score (SD)	14.21(3.63)	13.79(4.01)	0.609
SAS score (SD)	46.43(4.45)	47.43(6.66)	0.791
SDS score (SD)	62.93(8.81)	62.93(4.50)	1.000
wActiSleep-BT related data (SD)
TST	388.27(52.71)	384.45(43.73)	0.900
SE	78.28(9.08)	78.96(8.77)	0.655
SA	23.11(7.43)	21.49(7.84)	0.177
AA	4.79(2.62)	4.98(2.28)	0.480
WASO	94.30(46.20)	109.57(45.17)	0.069
TCM syndrome, n (%)			0.826
Kidney yang and yin deficiency	12 (28.57)	12 (28.57)
Kidney yang deficiency	22 (52.38)	15 (35.71)
Kidney yin deficiency	8 (19.05)	15 (35.71)
Expectation of acupuncture, n (%)			0.135
Complete believe	10 (23.81)	15 (35.71)
Believe	26 (61.90)	24 (57.14)
Little believe	3 (7.14)	2 (4.76)
Suspect	3 (7.14)	1 (2.38)

Abbreviations: SD, standard deviation; PSQI, Pittsburgh Sleep Quality Index; Men-QoL, Menopause-specific Quality of Life; ISI, Insomnia Severity Index; SAS, Self-Rating Anxiety Scale; SDS, Self-Rating Depression Scale; TST, total sleep time; SE, sleep efficacy; SA, sleep awakenings; AA, average awakening; WASO, wake after sleep onset; TCM, traditional Chinese medicine.

Table 2 Changes from Baseline of PSQI and Men-QoL Outcomes at the End of Treatment (8-Week) and the 12-Week and the 20-Week Follow-Up Visits by Group

Outcome	Acupuncture Group (n=42)			Sham Acupuncture Group (n=42)			Difference Between Groups (95% CI)	P
	Mean	SD		Mean	SD
PSQI score
Week 4	−1.93		2.15	−0.98		2.28	−0.95 (−2.03~0.13)	0.084
Week 8	−3.76		2.41	−1.38		2.94	−2.38 (−3.46~-1.30)	<0.001
Week 12	−4.24		2.83	−0.69		2.47	−3.55 (−4.63~-2.47)	<0.001
Week 20	−4.40		3.00	−0.76		2.27	−3.64 (−4.72~-2.56)	<0.001
Men- QoL score
Vasomotor
Week 4	−0.46		1.24	−0.03		0.82	−0.43 (−0.89~0.03)	0.066
Week 8	−1.13		1.18	0.10		1.00	−1.22 (−1.70~-0.75)	<0.001
Week 12	−0.97		1.22	0.30		0.81	−1.27 (−1.72~-0.82)	<0.001
Week 20	−1.15		1.15	0.20		0.66	−1.35 (−1.76~-0.94)	<0.001
Psychosocial
Week 4	−0.32		0.82	−0.23		0.84	−0.09 (−0.45~0.27)	0.613
Week 8	−0.53		0.89	−0.33		1.09	−0.20 (−0.63~0.23)	0.365
Week 12	−0.47		0.81	−0.18		1.01	−0.29 (−0.69~0.11)	0.152
Week 20	−0.45		0.91	−0.10		0.94	−0.36 (−0.76~0.04)	0.081
Physical
Week 4	−0.62		0.86	−0.22		0.70	−0.40 (−0.75~-0.06)	0.021
Week 8	−0.84		0.93	−0.15		0.88	−0.69 (−1.09~-0.30)	<0.001
Week 12	−0.78		0.79	0.02		0.66	−0.80 (−1.12~-0.49)	<0.001
Week 20	−0.74		0.91	0.11		0.55	−0.85 (−1.18~-0.53)	<0.001
Sexual
Week 4	0.03		0.87	−0.16		1.09	0.19 (−0.24~0.62)	0.377
Week 8	−0.13		1.14	−0.23		0.97	0.10 (−0.36~0.56)	0.682
Week 12	−0.10		1.21	0.04		0.95	−0.14 (−0.61~0.34)	0.571
Week 20	0.06		1.31	0.29		0.97	−0.23 (−0.74~0.26)	0.345

Abbreviations: SD, standard deviation; CI, confidence interval; PSQI, Pittsburgh Sleep Quality Index; Men-QoL, Menopause-specific Quality of Life.

Table 3 Seven Components of PSQI Changes from Baseline to the End of Treatment (8-Week) and the 12-Week and the 20-Week Follow-Up Visits by Group

Outcome	Acupuncture Group (n=42)		Sham Acupuncture Group (n=42)			Difference Between Groups (95% CI)	P
	Mean	SD	Mean		SD
PSQI score
Sleep quality
Week 4	−0.46	0.67	−0.26	0.77		−0.20 (−0.50~0.10)	0.188
Week 8	−0.90	0.58	−0.38	0.79		−0.52 (−0.82~-0.22)	<0.001
Week 12	−0.93	0.61	−0.26	0.73		−0.67 (−0.97~-0.36)	<0.001
Week 20	−0.98	0.65	−0.17	0.70		−0.81 (−1.11~-0.51)	<0.001
Sleep latency
Week 4	−0.15	0.79	−0.31	0.75		0.16 (−0.17~0.50)	0.337
Week 8	−0.49	0.81	−0.29	0.81		−0.20 (−0.54~0.13)	0.234
Week 12	−0.71	0.81	−0.17	0.82		−0.54 (−0.87~-0.21)	0.002
Week 20	−0.66	0.73	−0.14	0.75		−0.52 (−0.85~-0.18)	0.003
Sleep duration
Week 4	−0.39	0.59	−0.05	0.54		−0.34 (−0.62~-0.07)	0.015
Week 8	−0.78	0.69	−0.07	0.60		−0.71 (−0.98~-0.43)	<0.001
Week 12	−0.78	0.76	0.12	0.55		−0.90 (−1.17~-0.62)	<0.001
Week 20	−0.85	0.85	0.07	0.46		−0.92 (−1.20~-0.65)	<0.001
Habitual sleep efficiency
Week 4	−0.59	1.14	−0.10	0.66		−0.49 (−0.90~-0.08)	0.019
Week 8	−1.07	1.01	−0.12	0.86		−0.95 (−1.36~-0.54)	<0.001
Week 12	−1.05	1.07	−0.02	0.84		−1.03 (−1.43~-0.61)	<0.001
Week 20	−1.05	1.12	−0.05	0.79		−1.00 (−1.41~-0.59)	<0.001
Sleep disturbance
Week 4	−0.36	0.66	−0.12	0.59		−0.24 (−0.51~0.03)	0.085
Week 8	−0.50	0.63	−0.17	0.62		−0.33 (−0.60~-0.06)	0.016
Week 12	−0.50	0.67	−0.10	0.62		−0.40 (−0.68~-0.13)	0.004
Week 20	−0.52	0.63	−0.12	0.63		−0.40 (−0.68~-0.13)	0.004
Use of sleeping medication
Week 4	−0.05	0.22	−0.17	0.76		0.12 (−0.23~0.47)	0.504
Week 8	−0.05	0.62	−0.29	0.92		0.24 (−0.11~0.59)	0.182
Week 12	−0.12	1.04	−0.24	0.85		0.12 (−0.23~0.47)	0.504
Week 20	−0.14	0.90	−0.36	1.03		0.21 (−0.14~0.57)	0.230
Daytime dysfunction
Week 4	−0.17	0.49	−0.26	0.54		0.09 (−0.19~0.38)	0.511
Week 8	−0.24	0.62	−0.36	0.73		0.12 (−0.17~0.40)	0.411
Week 12	−0.43	0.70	−0.31	0.64		−0.12 (−0.40~0.17)	0.411
Week 20	−0.48	0.86	−0.29	0.67		−0.19 (−0.48~0.09)	0.189

Abbreviations: SD, standard deviation; CI, confidence interval; PSQI, Pittsburgh Sleep Quality Index.

Figure 2 Adjusted mean (95% CI) change from baseline in PSQI scores.

Note: *P<0.05 vs sham acupuncture group.

Table 4 Actigraphy Assessments at Baseline and the End of Treatment (Week 8) by Group

Outcome	Acupuncture Group (n=42)		Sham Acupuncture Group (n=42)		Difference Between Groups (95% CI)	P
	Mean	SD	Mean	SD
TST
Baseline	388.27	52.71	384.45	43.73	–	0.900
Week 8	405.64	61.19	372.39	47.84	28.80 (7.75~49.84)	0.007*
SE
Baseline	78.28	9.08	78.96	8.77	–	0.655
Week 8	81.14	7.89	76.61	9.28	5.16(2.00~8.32)	0.023*
SA
Baseline	23.11	7.43	21.49	7.84	–	0.177
Week 8	21.50	6.02	20.83	7.02	−0.95(−4.58~2.68)	0.639
AA
Baseline	4.79	2.62	4.98	2.28	–	0.480
Week 8	4.19	1.59	5.35	2.45	−0.97(−1.90~-0.05)	0.011*
WASO
Baseline	103.00	47.56	101.41	48.01	-	0.671
Week 8	94.30	46.20	109.57	45.17	−16.73(−34.50~1.03)	0.069

Note: *P<0.05.

Abbreviations: SD, standard deviation; TST, total sleep time; SE, sleep efficacy; SA, sleep awakenings; AA, average awakening; WASO, wake after sleep onset.

Table 5 ISI, SAS and SDS Outcomes at Baseline and the End of Treatment (Week 8) by Group

Outcome	Acupuncture Group (n=42)		Sham Acupuncture Group (n=42)		Difference Between Groups (95% CI)	P
	Mean	SD	Mean	SD
ISI
Baseline	14.21	3.63	13.79	4.01	–	0.609
Week 8	8.86	3.88	12.50	5.15	−4.10(−5.61~-2.58)	<0.001*
SAS
Baseline	46.43	4.45	47.43	6.66	-	0.791
Week 8	44.98	3.85	48.10	6.04	−2.07(−3.90~-0.24)	0.007*
SDS
Baseline	62.93	8.81	62.93	4.50	-	1.000
Week 8	62.38	5.49	63.57	5.23	−1.09(−3.74~1.55)	0.218

Note: *P<0.05.

Abbreviations: SD, standard deviation; ISI, Insomnia Severity Index; SAS, Self-Rating Anxiety Scale; SDS, Self-Rating Depression Scale.

Table 6 Use of Estazolam for Insomnia, by Group, n (%)

Group Allocation	Baseline (Yes)		Baseline (No)
	Follow-Up (Yes)	Follow-Up (No)	Follow-Up (Yes)	Follow-Up (No)
Acupuncture (n = 42)	6(14.3)	3(7.1)	0(0)	33(78.6)
Sham acupuncture (n = 42)	10(23.8)	0(0)	1(2.4)	31(73.8)

Table 7 Results of the Blinding, by Group

Group Allocation	Treatment Guess After End of Treatment, n (%)			Bang Blinding Index (95% CI)
	Acupuncture	Sham Acupuncture	Unsure
Acupuncture (n = 42)	18(42.8)*	2(4.8)	22(52.4)	0.38(0.21 to 0.55)
Sham acupuncture (n = 42)	15(35.7)	9(21.4)*	18(42.9)	−0.14(−0.36 to 0.08)

Note: *Correct guess.

Table 8 Adverse Events, by Group, n (%)

Group Allocation	Acupuncture (n = 42)	Sham Acupuncture (n = 42)
Adverse events reported, n (%)	2(4.8)	1(2.4)
Adverse events (intensity), n
Bleeding	1(mild)	0
Pain	1(mild)	1(mild)